PROMETHAZINE HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Mevcut itibaren:

KVK-Tech, Inc.

INN (International Adı):

PROMETHAZINE HYDROCHLORIDE

Kompozisyon:

PROMETHAZINE HYDROCHLORIDE 12.5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Promethazine hydrochloride tablets, USP are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients. Promethazine hydrochloride tablets, USP are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets, USP are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.

Ürün özeti:

Promethazine hydrochloride tablets, USP for oral administration are available as : 12.5 mg: Orange colored, round shaped, biconvex tablets, debossed “K” on left and “2” on right of bisect, on one side and plain on the other side and are supplied as: NDC 10702-002-01 bottles of 100 NDC 10702-002-10 bottles of 1000 25 mg: White colored, round shaped, flat face bevel edge tablets, debossed “K 3” on one side and quadrisected on the other side and are supplied as: NDC 10702-003-01 bottes of 100 NDC 10702-003-50 bottles of 500 NDC 10702-003-10 bottles of 1000 50 mg: Pink colored, round shaped, biconvex tablets, debossed “K 4” on one side and plain on the other side and are supplied as: NDC 10702-004-01 bottles of 100 NDC 10702-004-10 bottles of 1000 Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required). Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940-1850 Item ID # 006025/04 02/2024 Manufacturer’s Code: 10702

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
KVK-TECH, INC.
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PROMETHAZINE HYDROCHLORIDE TABLETS, USP
DESCRIPTION
Promethazine hydrochloride, USP a phenothiazine derivative, is
designated chemically as
(±)-10-[2-(Dimethylamino)propyl]phenothiazine monohydrochloride and
has the
following structural formula:
Promethazine hydrochloride, USP is a racemic compound; the molecular
formula is C
H
N
S•HCl and its molecular weight is 320.88.
Promethazine hydrochloride, USP occurs as a white to faint yellow,
practically odorless,
crystalline powder which slowly oxidizes and turns blue on prolonged
exposure to air. It
is freely soluble in water and soluble in alcohol.
Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg
of promethazine
hydrochloride, USP. The inactive ingredients include: lactose
monohydrate, magnesium
stearate and microcrystalline cellulose. In addition, 50 mg tablet
contains FD&C Red #40
and 12.5 mg tablet contains FD&C Yellow #6.
CLINICAL PHARMACOLOGY
Promethazine is a phenothiazine derivative which differs structurally
from the
antipsychotic phenothiazines by the presence of a branched side chain
and no ring
substitution. It is thought that this configuration is responsible for
its relative lack (1/10
that of chlorpromazine) of dopamine antagonist properties.
Promethazine is an H
receptor blocking agent. In addition to its antihistaminic action, it
provides clinically useful sedative and antiemetic effects.
Promethazine is well absorbed from the gastrointestinal tract.
Clinical effects are
apparent within 20 minutes after oral administration and generally
last four to six hours,
although they may persist as long as 12 hours. Promethazine is
metabolized by the liver
to a variety of compounds; the sulfoxides of promethazine and
_N-_demethylpromethazine are the predominant metabolites appearing in
the urine.
INDICATIONS AND USAGE
Promethazine hydrochloride tablets, USP are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
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20
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Allergi